Location: Leiden, ZH, Netherlands
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech
Discover new opportunities to grow your career as a Covance's Clinical Research Associate.
Covance is looking to hire SCRA - sponosor dedicated
- all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
- all aspects of site management as prescribed in the project plans
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
- Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements
- Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
- Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems
- University degree - Life Science
- Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Excellent understanding of Serious Adverse Event (SAE) reporting
- Ability to resolve project-related problems and prioritize workload for self and team
- You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).
- Ducth and English is must
Apply on company website